Kornimate/medical-research-clean huggingface dataset:
stellate ganglion blockade in corona virus 2019 (covid-19) positive patients

Conditions: COVID 19; ARDS

Summary: this study will establish the safety and efficacy of using stellate ganglion blocks in patients with acute respiratory distress syndrome (ards) due to covid-19 disease.

the stellate ganglion block (sgb) will be performed in the icu. nurse will provide patient monitoring and assistance during the procedure. standard monitors and advanced cardiovascular life support (acls) resuscitative equipment will be immediately available. a norepinephrine solution will be at bedside to treat potential hypotension associated with sgb. the sgb perineural catheter will be placed using standard sterile technique. initial perineural bolus injection - clonidine 100 mcg, decadron sodium phosphate (pf) 5mg, and 0.25% bupivacaine 5 ml is delivered. an onq brand perineural infusion 0.2% bupivacaine will be initiated at 2ml/hr for 5 days. acute pain service will discontinue infusion and remove the catheter after 5 days.

Eligibility criteria:
inclusion criteria: * any patient between the ages of 19-85 with laboratory established covid-19 infection via real-time reverse transcription-polymerase chain reaction (rrt-pcr) requiring critical care in an intensive care unit. * signs or symptoms consistent with ards must be present. * the syndrome must present acutely, ratio of arterial oxygen partial pressure to fractional inspired oxygen (pao2/fio2) ≤ 200 mm hg, bilateral infiltrates on chest radiograph or ct not due to cardiac failure, need for non-invasive or invasive mechanical ventilation, and any cardiac dysrhythmia (excluding sinus tachycardia). exclusion criteria: * hemodynamic instability (\>2 vasopressors) * pre-hospital diagnosis of heart failure or fluid overload * anatomical inability to perform block * prior sympathectomy * patient currently enrolled in another clinical trial for covid-19 or respiratory distress/acute respiratory distress syndrome (ards) * uncorrectable coagulopathy, already on extracorporeal membrane oxygenation (ecmo), already on nitric oxide, pre-existing multi-organ failure (\>2 organ systems).

Keywords: stellate ganglion perineural block
evaluating the effectiveness of a family heart health educational program (the fit-heart study)

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: the primary objective of the fit heart study was to test the effectiveness of a hospital-based standardized screening and educational intervention targeted to family members of patients hospitalized with cvd, to increase adherence to cvd prevention guidelines.

fit heart was a randomized controlled trial that tested a novel systems approach to increase adherence to national prevention guidelines among family members of patients hospitalized with cvd. participants were blood relatives or cohabitants of patients hospitalized with atherosclerotic cardiovascular disease, aged 20-79 years, did not have established cardiovascular disease or diabetes, and spoke english or spanish. participants randomized to a special intervention group received behavioral counseling and education on diet and physical activity; personalized risk factor screening and immediate feedback; and reinforcement and follow-up throughout the year. the control group received a brief cvd prevention message in the form of a handout. all participants received standardized assessments of diet, lifestyle, and cvd risk factors at baseline and 1 year (94% follow-up). the main findings have been published showing the mean percent change in ldl-cholesterol level from baseline to 1-year improved in both groups and was not significantly different in the special intervention vs. control group (-1% vs. -2%; p=.64).

Eligibility criteria:
inclusion criteria: * life expectancy of at least 5 years after study entry * willing to return at year 1 for a repeat study evaluation * family member was hospitalized with acute atherosclerotic cardiovascular disease, including catheter-based procedures and coronary artery bypass grafting * speaks either english or spanish exclusion criteria: * established cardiovascular disease, diabetes, active liver disease, or long-term kidney disease * life expectancy less than 5 years from study entry * prescription of a special diet that is not compatible with the tlc diet * participation in a clinical drug study in the 3 months before study entry * pregnant or planning to become pregnant

Keywords: prevention
multicenter prospective cohort study of risk factors for gallbladder cancer

Conditions: Gallbladder Diseases; Healthy

Summary: this trial is a prospective study, the main purpose of the study is to investigate the association between benign gallbladder disease and gallbladder carcinoma; to explain the timing of intervention, intervention and early prevention of benign gallbladder disease; according to the national epidemiology of gallbladder cancer center clinical research (unpublished), 2000 national cholecystoma clinical epidemiology report, and 2005 clinical analysis of 2379 cases of gallbladder carcinoma in 17 hospitals in five northwest provinces, pre-experimental data, using samples the volume estimation formula, α = 0.05, β = 0.1, plans to enroll 100,000 people.half of participants is someone with biliary benign disease，while the other half is healthy.

gallbladder cancer is the most common malignant biliary tract tumor. the main risk factors for gallbladder cancer include gallstones, gallbladder polyps, gallbladder adenomas, chronic inflammation of the gallbladder, etc. however, recently, there is still a lack of evaluation data on relevant risk factors. therefore, on the basis of large-scale epidemiological investigations, large-scale prospective studies are needed to further clarify the level of risk factors associated with gallbladder cancer. with the development of modern imaging technology and deep understanding of gallbladder diseases, the detection rate of benign gallbladder lesions (cacerous polyps, gallbladder adenomyosis, gallbladder adenoma, gallstones, etc.) has increased year by year, and some benign gallbladder lesions can pass a series of pathophysiological processes have gradually evolved into gallbladder cancer. this study aimed to establish a prospective cohort of benign gallbladder disease, to explore the correlation, intervention time and socioeconomic benefits of benign gallbladder disease and gallbladder cancer. in order to further understand the current trend and diagnosis and treatment of benign gallbladder disease in china, the chinese society of surgery branch of the chinese society of surgery will launch a national epidemiological survey of gallbladder cancer (2018). this study will provide a more detailed basis for the diagnosis and treatment of benign gallbladder disease in china.

Eligibility criteria:
inclusion criteria: * subjects who met the following four criteria entered the study. 1. a benign gallbladder disease is detected during a medical examination or visit (according to any imaging test); 2. healthy people without gallbladder disease; 3. age greater than 18 years and less than 80 years old; 4. sign the informed consent form. ps: if someone meets the condition (1) or (2), then he can be enrolled. exclusion criteria: * subjects can not enter the study by combining any of the following 1. concomitant diseases such as severe mental illness, severe heart, lung and kidney; 2. refusal of follow-up requirements.

Keywords: gallbladder cancer
clinical & radiographic evaluation of zinc oxide-ozonated oil as a new primary root canal filling

Conditions: Pulp Disease, Dental; Obturation; Root Canal Infection

Summary: preserving primary teeth is essential for many aspects such as the child's growth and development, esthetic, functional, psychological, and dental arch integrity aspects. a randomized blinded controlled clinical trial aimed to evaluate the clinical and radiographic success of zinc oxide-ozonated olive oil as root canal filling materials for primary molars compared to zinc oxide-olive oil \& zinc oxide-eugenol. 90 primary molars of 30 children aged between 4-8 years with pulpally involved primary molars, are equally divided into 3 groups which treated with zinc oxide-ozonated olive oil , zinc oxide -olive oil and zinc oxide eugenol as obturation materials following pulpectomy procedure. the subjects were followed up clinically and radiographically at 3, 6 and 12 months.

pulpectomy for primary teeth involves root canal preparation followed by obturation with a resorbable material. zinc oxide eugenol (zoe) is the most widely used obturating material. the main zoe disadvantages are the difference in rate of resorption compared to the root, and limited antimicrobial activity. zoe is formed when crude eugenol is mixed with zinc oxide. the set material easily hydrolyzes, resulting in free eugenol release which can be harmful to human soft tissues; this motivated the search for a new eugenol substitute to be combined with zinc oxide. olive oil is a vegetable oil that comprises antioxidants, carotenoids, oleuropein, and oleocanthal, a phenolic component that significantly contributes to its antibacterial and anti-inflammatory properties. ozone in the form of ozonated olive oil, have the ability to produce nascent oxygen deep into the treated area without triggering irritation so, improved rheological characteristics, increased intracellular atp, stimulated cellular metabolism, and expression of cytokines related to healing, particularly transforming growth factor.

Eligibility criteria:
inclusion criteria: * healthy \& cooperative child * history of spontaneous pain * percussion sensitivity * presence of inter-radicular or periapical radiolucency * no internal root resorption * external root resorption limited to apical third and with at least two-thirds root intact. exclusion criteria: * uncooperativeness of child and/or parents * unrestorable tooth * presence of calcific metamorphosis inside root canals * tooth with evidence of extensive internal/external pathological root resorption.

Keywords: pulpectomy ozonated olive oil zinc oxide eugenol primary molars
cannabidiol oral solution as an adjunctive therapy for treatment of participants with inadequately controlled lennox-gastaut syndrome

Conditions: Lennox-Gastaut Syndrome

Summary: this phase 3 trial will enroll participants diagnosed with lennox-gastaut syndrome (lgs) who are still experiencing at least 4 motor seizures involving the trunk or extremities per week, despite ongoing treatment with up to 3 antiepileptic drugs (aeds) and who meet inclusion/exclusion criteria. following a 28-day baseline period, participants will begin an 84-day treatment period. participants will be assigned to receive twice daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial. following study completion, all participants will be invited to receive cannabidiol oral solution in an open label extension study (under a separate protocol).


Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification and contraception, including clinical diagnosis of refractory lgs and onset of seizures according to protocol-specified criteria * is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the institutional review board before the conduct of any study procedure * in the opinion of the investigator, the participants and parent(s)/caregiver(s) are willing and able to comply with the study procedures and visit schedules, including venipuncture, twice daily dosing, accurate diaries, and the follow-up visits (if applicable). exclusion criteria: * medical history is outside protocol-specified parameters * clinically significant history of allergic reactions or significant sensitivities to cannabinoids or to any of the other ingredients in the study drug * inadequate supervision by parents or guardians * history or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters * signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

Keywords: treatment-resistant seizures
effect of acetazolamide on exercise performance in patients with respiratory disease at altitude

Conditions: Chronic Obstructive Pulmonary Disease

Summary: in this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on exercise performance at altitude in patients with copd.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on exercise performance in lowlanders with chronic obstructive pulmonary disease travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3200 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo), will be administered 24 hours before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3200 m. exercise performance will be evaluated by maximal cycling spiroergometry and constant load ergometry.

Eligibility criteria:
inclusion criteria: * male and female patients, age 18-75 yrs. * copd diagnosed according to gold, fev1 40-80% predicted, spo2 ≥92% at 750 m. * born, raised and currently living at low altitude (\<800m). * written informed consent. exclusion criteria: * copd exacerbation, very severe copd with hypoxemia at low altitude (fev1/fvc \<0.7, fev1 \<40% predicted, oxygen saturation on room air \<92% at 750 m). * comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; osa; pneumothorax in the last 2 months. * internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day) * known renal failure or allergy to acetazolamide and other sulfonamides

Keywords: exercise performance maximal spiroergometry airway disease emphysema prevention acetazolamide altitude
evaluation of innolia htlv i/ii score

Conditions: Human T-Lymphotrophic Virus Type I and/or Type II

Summary: the innolia htlv i/ii score is an in vitro diagnostic test for confirmation of antibodies to human t-cell lymphotropic virus (htlv) type i and type ii in human blood samples. it is intended as a supplemental test for blood donor samples that are reactive in routine anti-htlv screening tests. this study will determine if the test is useful for donor counseling purposes.

the innolia htlv i/ii score study consists of three sub-studies. the first sub-study will determine the sensitivity, specificity and accuracy of htlv type assignment using well-characterized samples from the nih-funded htlv outcomes study (host). the second sub-study will compare automated reading and interpretation of test results with manual reading and interpretation using a sub-set of samples tested in the initial study. the third sub-study allows for use of the innolia htlv i/ii score as a supplemental test for whole blood and hct/p donors testing repeatedly reactive with an fda-approved donor screening test for anti-htlv-i/ii.

Eligibility criteria:
inclusion criteria: * subjects completing a health history evaluation for routine donor screening * subjects willing and able to provide informed consent * subjects testing repeat reactive on a licensed screening test for htlv antibodies exclusion criteria: * subjects not meeting health history criteria for routine donor screening * subjects unwilling and unable to provide informed consent * subjects testing negative on a licensed screening test for htlv antibodies

Keywords: htlv htlv i htlv ii htlv type i and/or htlv type ii antibody
safety and efficacy study of enzalutamide plus leuprolide in patients with nonmetastatic prostate cancer (embark)

Conditions: Hormone Sensitive Prostate Cancer; Prostate Cancer; Cancer of the Prostate

Summary: the purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. the randomized / blinded portion of the study is now completed following primary endpoint analyses. the study remains ongoing in open label format.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features; * prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent; * psa doubling time ≤ 9 months; * screening psa by the central laboratory ≥ 1 ng/ml for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/ml above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer; * serum testosterone ≥ 150 ng/dl (5.2 nmol/l). exclusion criteria: * prior or present evidence of distant metastatic disease as assessed by radiographic imaging; * prior hormonal therapy. neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising psa ≥ 9 months before randomization is allowed.; * prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer; * prior systemic biologic therapy, including immunotherapy, for prostate cancer; * major surgery within 4 weeks before randomization; * treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization; * known or suspected brain metastasis or active leptomeningeal disease; * history of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
hrad-vascular access

Conditions: Anxiety; Vascular Access

Summary: the perioperative setting is a common site of pediatric anxiety and distress. perioperative anxiety in pediatric patients can result in uncooperative behavior, poor postoperative outcomes, and trauma. given the fast-paced nature of the perioperative environment, many anxiety measures are too time consuming for clinical implementation prior to surgery. pediatric anesthesiologists need reliable and efficient assessment tools to quickly measure childhood distress to target prophylactic and therapeutic interventions.


Eligibility criteria:
inclusion criteria: * participants who is undergoing vascular access exclusion criteria: * clinically unstable
investigating whether acute elevation of fatty acid levels alters cerebral glucose transport and metabolism

Conditions: Obesity

Summary: the goal of this study is to understand the role of brain glucose transport in individuals with obesity and the association with cerebral hypometabolism and these individuals' response to plasma glucose elevations. the main premise is that obesity leads to reduced brain glucose transport and that we can measure this reduction with magnetic resonance spectroscopy (mrs). the secondary premises are that this reduction is driven by elevated non esterified fatty acids which act to turn on specific signaling pathways that regulate brain glut1 levels.

there are 2 aims of this study. the intent of aim 1 is to measure the effect of obesity on glucose transport and metabolism in the human brain. this study aim will be conducted in non-diabetic, obese individuals and age- and hba1c-matched normal weight individuals. a total of 15 non-diabetic - normal weight individuals and 15 obese individuals will be enrolled. the second aim randomizes 40 non-diabetic, normal weight individuals. the intent of aim 2 is to determine whether acute elevation of nefa levels in lean, healthy individuals will alter cerebral glucose transport. eligible participants will be randomized (1:1) to receive either intralipid or normal saline. the focus of this protocol registration is the randomized portion of the study (aim 2).

Eligibility criteria:
inclusion criteria: * age 18-45 years * hba1c \<6.5% * normal weight individuals: bmi 17-25 kg/m\^2 * obese individuals: bmi \>30 kg/m\^2 exclusion criteria: * creatinine \>1.5mg/dl * hematocrit \<35% for females and \<39% for males * alt and ast \>2.5x upper limit of normal * abnormal tsh * abnormal pt/ptt/inr * triglycerides \>200 mg/dl * known hepatic, gastrointestinal, renal, neurologic, psychiatric, cerebrovascular disease * uncontrolled hypertension * current or past 3 months use of ketogenic diet * use of any medications, vitamins, or supplements that can alter cerebral metabolism or lipids * smoking * current or recent steroid use in last 6 months * \>5% body weight change in last 6 months * illicit drug use/alcoholism * inability to enter mri/mrs * for women: pregnancy, seeking pregnancy, or breastfeeding
controlled study of ono-5334 in postmenopausal women with osteopenia or osteoporosis

Conditions: Osteoporosis; Osteopenia

Summary: the purpose of this study is to evaluate the efficacy and safety of ono-5334 in postmenopausal women with osteopenia or osteoporosis.


Eligibility criteria:
inclusion criteria: 1. osteoporosis defined as a value dxa bmd 2.5 sd or more below the young adult mean (t-score, ≤-2.5) at the lumbar spine (l1 to l4) or total hip, or * osteoporosis defined as a value of dxa bmd more than 1 sd below the young adult mean, but less than 2.5 sd below this value (t-score \ 2.5) at the lumbar spine (l1 to l4) or total hip. exclusion criteria: 1. patients with a value of dxa bmd more that 3.5 sd below the young adult mean, (t-score \<-3.5) at the lumbar spine (l1 to l4) or total hip. 2. osteoporosis patients (t-score ≤-2.5) who have any vertebral fragility fracture between t4 and l4 inclusive. 3. osteopenia patients (t-score \ -2.5) who have no vertebral fragility fractures between t4 and l4 inclusive, or * osteopenia patients (t-score \ -2.5) who have two or more vertebral fragility fractures between t4 and l4 inclusive. 4. patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of bmd. 5. patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism. 6. other exclusion criteria as specified in the study protocol.

Keywords: ono-5334 osteoporosis osteopenia
mac bipsectral index below 50 for chronic opioid user

Conditions: Anesthesia

Summary: the purpose of this study is to find difference in minimum alveolar concentration(mac) for maintaining bispectral index (bis) below 50 between chronic opioid users and opioid naive patients.

1. patients selection in elective surgery which need general anesthesia. 2. mac bis50 data was collected in each patients (by blinded investigator) 3. the data collection will be continued for enough sample size for using dixon up down method analysis 4. after data collection, mac bis below 50 will be analyzed in both groups ( chronic opioid users versus opioid naive patients)

Eligibility criteria:
inclusion criteria: * the patients(asa class i-iii) who receive elective surgery * signed in informed consent to participate in this trial voluntarily. exclusion criteria: * history of monoamine oxidase (mao) inhibitor use * chronic alcoholics * acute alcohol abuser * contraindication for inhalation agent use (sevoflurane) * bmi \>30 * history of medication use, which affect in the minimum concentration of sevoflurane;(barbiturates, chlorpromazine, diazepam, hydroxyzine, verapamil, marijuana) * craniotomy

Keywords: minimum alveolar concentration